FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE
K Number: K011825
·
Decision Jul 11, 2001
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
26
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE
- K Number
- K011825
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sightline Technologies , Ltd.
- Date Received
- June 11, 2001
- Decision Date
- July 11, 2001
- Product Code
- FER
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FER | Anoscope And Accessories | FDA class 2 | Gastroenterology, Urology |
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